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Stryker recall CoCr V40 Femoral Heads

The Medicines & Healthcare products Regulatory Agency (MHRA) has published an Urgent Field Safety Notice for the Stryker LFIT Anatomic CoCr V40 Femoral Heads announcing a recall of the product. This follows a ‘Hazard alert’ made by the Therapeutic Goods Administration (TGA) in Australia on 27th September on the same femoral head models.

Femoral Heads are the rounded tip of the thigh bone which is attached to the hip. In replacement hips the Femoral Head is a component part, a ball of ceramic or metal, used in total hip replacement procedures which allow the hip to move as it would naturally.

Stryker has received higher than expected complaints of taper lock failure on certain Femoral Heads manufactured between 1 January 2002 and 4 March 2011. The taper lock connects the femoral head to the femoral neck, the main segment of the hip replacement.

If the taper lock should fail, patients may suffer serious complications such as dislocation, loss of mobility, joint instability, user annoyance, adverse local tissue reaction, leg length discrepancy, inflammation or pain due to the implant loosening. These complications may lead to revision surgery to correct the component. According to Stryker, the affected products are either expired or already implanted.

Jill Paterson, partner in law firm Leigh Day’s product liability team, said: “The starting point is that patients should be able to expect that the medical implants they receive are safe, especially where there is the abnormal potential for damage.”

Patients who think they may be affected should contact their hospital or surgeon for clinical advice.

Compare jurisdictions:Life Sciences: Product Regulation and Liability

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